Press Release: FDA accepts Dupixent® (dupilumab) for Priority
Review in patients aged 12 years and older with eosinophilic
esophagitis
FDA accepts Dupixent® (dupilumab) for Priority
Review in patients aged 12 years and older with eosinophilic
esophagitis
- If approved, Dupixent would be the
first medicine available in the U.S. indicated to treat
eosinophilic esophagitis
- There are approximately 160,000
patients in the U.S. living with eosinophilic esophagitis who are
currently treated, of whom approximately 48,000 have failed
multiple treatments
Paris and Tarrytown,
N.Y., April
4, 2022. The
U.S. Food and Drug Administration (FDA) has accepted for Priority
Review the supplemental Biologics License Application (sBLA) for
Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric
patients aged 12 years and older with eosinophilic esophagitis
(EoE), a chronic and progressive type 2 inflammatory disease that
damages the esophagus and impairs the ability to swallow. The
target action date for the FDA decision on this investigational use
is August 3, 2022.
The sBLA is supported by data from two Phase 3
trials evaluating the efficacy and safety of Dupixent 300 mg weekly
in patients aged 12 years and older with EoE (Part A and Part B),
and data from an active long-term extension trial. Dupixent 300 mg
weekly significantly improved the signs and symptoms of EoE at 24
weeks compared to placebo, including the ability to swallow and
reduction in eosinophil count in the esophagus. The safety results
of these trials were generally consistent with the known safety
profile of Dupixent in its approved indications. The most common
adverse event observed with Dupixent, in Part A and Part B, was
injection site reactions.
In September 2020, the U.S. FDA granted
Breakthrough Therapy designation to Dupixent for the treatment of
patients aged 12 years and older with EoE. Dupixent was also
granted Orphan Drug designation for the potential treatment of EoE
in 2017. Priority review is granted to therapies that have the
potential to provide significant improvements in the treatment,
diagnosis or prevention of serious conditions. Regulatory filings
around the world are also planned in 2022. The potential use of
Dupixent in EoE is currently under clinical development, and the
safety and efficacy have not been fully evaluated by any regulatory
authority.
About Eosinophilic
Esophagitis (EoE)
EoE is a chronic, progressive type 2
inflammatory disease that damages the esophagus and prevents it
from working properly. For people with EoE, swallowing the smallest
amount of food can be a painful and worrisome choking experience.
Those with EoE live with anxiety and frustration from having a
constantly evolving list of foods to avoid. This disease can also
cause narrowing of the esophagus and dilation (physical expansion)
of the esophagus may be needed, which is often painful. In severe
cases, a feeding tube is the only option to ensure proper caloric
intake and adequate nutrition. People with EoE may have poor
quality of life and are more likely to experience depression than
people without EoE. There are approximately 160,000 patients in the
U.S. living with EoE who are currently treated, of whom
approximately 48,000 have failed multiple treatments.
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
In the U.S., Dupixent is approved in patients
aged 6 years and older with uncontrolled moderate-to-severe atopic
dermatitis; as an add-on maintenance treatment of patients aged 6
years and older with moderate-to-severe asthma characterized by an
eosinophilic phenotype or with oral corticosteroid-dependent
asthma; and for use with other medicines for the maintenance
treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP)
in adults whose disease is not controlled.
Dupixent is also approved in Europe, Japan and
other countries around the world for use in specific patients with
moderate-to-severe atopic dermatitis and certain patients with
asthma or CRSwNP in different age populations. Dupixent is approved
in one or more of these indications in more than 60 countries
around the world, and more than 400,000 patients have been treated
globally.
Dupilumab Development
Program
Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type 2 inflammation or other allergic
processes, including eosinophilic esophagitis (Phase 3), pediatric
atopic dermatitis (6 months to 5 years of age, Phase 3), chronic
rhinosinusitis without nasal polyposis (Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), bullous pemphigoid (Phase 3), chronic
inducible urticaria-cold (Phase 3), allergic fungal rhinosinusitis
(Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and
peanut allergy (Phase 2). These potential uses of dupilumab are
currently under clinical investigation, and the safety and efficacy
in these conditions have not been fully evaluated by any regulatory
authority.
About Regeneron Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for nearly 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to nine FDA-approved treatments and numerous
product candidates in development, almost all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, pain, hematologic conditions, infectious diseases and
rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Sanofi Media RelationsSally
Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Sanofi Investor RelationsEva
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374 2422 | ashleigh.dixon@regeneron.com
Regeneron Investor RelationsVesna
Tosic | + 914 847 5443 | vesna.tosic@regeneron.com
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